Acute Coronary SyndromePhase 4EMSIACSNCT04100434
Effect of Evolocumab Added to Moderate-Intensity Statin Therapy on LDL-C Lowering and Cardiovascular Adverse Events in Patients With Acute Coronary Syndrome
A Phase 4 study testing Evolocumab in people with Acute Coronary Syndrome and Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor, run by Tianjin Chest Hospital at 1 site in China.
Trial summary
The study is an open-label, multicenter, and randomized study(five hospitals).The purpose of this study is to assess the differences in the effects of the evolocumab added to moderate-intensity statin therapy and the moderate-intensity statin only therapy on the regulation of LDL-C levels in patients with acute phase… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor
- What is being tested?
- Evolocumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 1 Jun 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recent hospitalization for acute coronary syndrome: Complies with the diagnostic criteria for acute coronary syndrome (non-ST-segment elevation myocardial infarction, acute ST-segment elevation myocardial infarction, and unstable angina within 72 hours of onset)
- LDL-C level (meet one of the following conditions):
- Prior to the study, patients who received intensive statins for more than 4 weeks (the same dose of statin therapy has been sustained for the past four weeks) with LDL-C levels ≥70 mg/dL (≥1.8 mmol/L) or non-HDL-C ≥100 mg /dL (≥2.6mmol/L) are included in the study;
- Prior to the study, patients who received moderate-intensity statin therapy for more than 4 weeks (the same dose of statin therapy has been sustained for the past four weeks) with LDL-C levels ≥90 mg/dL (≥2.3 mmol/L) or non-HDL-C≥ 120mg/dL (≥3.1mmol/L) are included in the study;
- Prior to the study, patients who do not receive statin therapy or who do not continue to receive statin with LDL-C ≥ 125 mg/dL (≥ 3.2 mmol/L) or non-HDL-C ≥ 155 mg/dL (≥ 4.0 mmol/L).
- Being able to understand research requirements and sign informed consent
Who cannot join
- Unstable clinical status (hemodynamics or ECG instability)
- Uncontrolled arrhythmia, defined as recurrent or symptomatic ventricular tachycardia and atrial fibrillation with rapid ventricular reaction that the drug cannot control within three months prior to screening
- Severe renal insufficiency, defined as estimated glomerular filtration rate<30ml/min/1.73m2
- Active liver disease or liver dysfunction, whether it is on the patient's medical record or defined as an increase in alanine aminotransferase or aspartate aminotransferase more than 3 times above the upper limit of normal
- Records on statin or rosuvastatin (any dose) intolerance or other statin intolerance
- Known allergies to contrast agents, heparin, aspirin, ticagrelor or clopidogrel
Show all 14Show fewer
- Known allergies to the supplements required for the use of the drug
- Patients who have been treated with evolocumab or other PCSK9 inhibitors
- Received cholesterol ester transfer protein inhibitors treatment 12 months prior to screening
- Received systemic steroid or cyclosporine treatment in the past 3 months
- Known infections, hemorrhages, metabolic or endocrine disorders as determined by the researchers
- Patients who have been included in other studies
- Patients with active malignant tumor in need of treatment
- Women with fertility (age <50 years, menstruation in the past 12 months), did not receive tubal ligation, oophorectomy or hysterectomy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Chest Hospital,
Tianjin, 300222
JING GAO, PH.D, 13820156072, gaojing2088@163.com
About this study
The study is an open-label, multicenter, and randomized study(five hospitals).The purpose of this study is to assess the differences in the effects of the evolocumab added to moderate-intensity statin therapy and the moderate-intensity statin only therapy on the regulation of LDL-C levels in patients with acute phase acute coronary syndrome after four weeks of treatment. The primary outcome is the percentage change in LDL-C in weeks 4 and week 12 after treatment. The secondary outcome is the occurrence of MACE after 12 weeks and 1 year of treatment.
- Being tested
- Evolocumab
- Keywords
- Acute Coronary Syndrome, Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor, Lipid-lowering Drug, Major Cardiovascular Adverse Events
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvolocumabDrug
Patients were randomly assigned of the ratio of 1:1 using a computer-generated random number and divided into two treatment groups: the statin alone therapy and the evolocumab plus statin therapy.
| Study group | Role | What they receive |
|---|---|---|
| the evolocumab plus statin therapy | Experimental | Patients with ACS are treated with atorvastatin (20mg) daily and evolocumab (140 mg) every two weeks throughout the study period Receives: Drug: Evolocumab |
| the statin alone therapy | No intervention | Patients with ACS are treated with atorvastatin (20mg) daily throughout the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in LDL-C
Measured: 4 weeks
Secondary outcomes (1)
Major cardiovascular adverse events
Coronary heart disease death，nonfatal myocardial infarction，hospitalization for unstable angina，unplanned coronary revascularization, and stroke
Measured: 4 weeks and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start1 Jan 2021 (estimated)
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yin Liu,MD, Tianjin Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04100434
- Sponsor's protocol ID
- EMSIACS
- Acronym
- EMSIACS
- Status last verified
- Nov 2020
- First submitted
- 21 Sep 2019
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jing A, Wang J, Zhang M, Liang Y, Liu J, Zhang N, Wang J, Li X, Li C, Cui Z, Liu Y, Gao J. Effect of PCSK9 inhibitors on the quality of life in patients with acute coronary syndromes - exploratory analysis of the EMSIACS trial. Sci Rep. 2025 Nov 27;15(1):42493. doi: 10.1038/s41598-025-26495-y.
PubMed 41309899Gao J, Liu JY, Lu PJ, Xiao JY, Gao MD, Li CP, Cui Z, Liu Y. Effects of Evolocumab Added to Moderate-Intensity Statin Therapy in Chinese Patients With Acute Coronary Syndrome: The EMSIACS Trial Study Protocol. Front Physiol. 2021 Nov 23;12:750872. doi: 10.3389/fphys.2021.750872. eCollection 2021.
PubMed 34887772
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Evolocumab Added to Moderate-Intensity Statin Therapy on LDL-C Lowering and Cardiovascular Adverse Events in Patients With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT04100434
- Acronym / sponsor ID
- EMSIACS / EMSIACS
- Keywords
- Acute Coronary Syndrome, Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor, Lipid-lowering Drug, Major Cardiovascular Adverse Events
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Tianjin Chest HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 24 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is an open-label, multicenter, and randomized study(five hospitals).The purpose of this study is to assess the differences in the effects of the evolocumab added to moderate-intensity statin therapy and the moderate-intensity statin only therapy on the regulation of LDL-C levels in patients with acute phase acute coronary syndrome after four weeks of treatment. The primary outcome is the percentage change in LDL-C in weeks 4 and week 12 after treatment. The secondary outcome is the occurrence of MACE after 12 weeks and 1 year of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the evolocumab plus statin therapy | Experimental | Drug: EvolocumabPatients with ACS are treated with atorvastatin (20mg) daily and evolocumab (140 mg) every two weeks throughout the study period |
| the statin alone therapy | No intervention | –Patients with ACS are treated with atorvastatin (20mg) daily throughout the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Recent hospitalization for acute coronary syndrome: Complies with the diagnostic criteria for acute coronary syndrome (non-ST-segment elevation myocardial infarction, acute ST-segment elevation myocardial infarction, and unstable angina within 72 hours of onset)
- LDL-C level (meet one of the following conditions):
- Being able to understand research requirements and sign informed consent
Key exclusion criteria (14 listed)
- Unstable clinical status (hemodynamics or ECG instability)
- Uncontrolled arrhythmia, defined as recurrent or symptomatic ventricular tachycardia and atrial fibrillation with rapid ventricular reaction that the drug cannot control within three months prior to screening
- Severe renal insufficiency, defined as estimated glomerular filtration rate<30ml/min/1.73m2
- Active liver disease or liver dysfunction, whether it is on the patient's medical record or defined as an increase in alanine aminotransferase or aspartate aminotransferase more than 3 times above the upper limit of normal
- Records on statin or rosuvastatin (any dose) intolerance or other statin intolerance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EvolocumabPatients were randomly assigned of the ratio of 1:1 using a computer-generated random number and divided into two treatment groups: the statin alone therapy and the evolocumab plus statin therapy. | Drug | the evolocumab plus statin therapy |
Primary outcome
Percent change in LDL-C
Time frame: 4 weeks
1 secondary outcome
Major cardiovascular adverse events
Time frame: 4 weeks and 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Derived from this study: PubMed 41309899Jing A, Wang J, Zhang M, Liang Y, Liu J, Zhang N, Wang J, Li X, Li C, Cui Z, Liu Y, Gao J. Effect of PCSK9 inhibitors on the quality of life in patients with acute coronary syndromes - exploratory analysis of the EMSIACS trial. Sci Rep. 2025 Nov 27;15(1):42493. doi: 10.1038/s41598-025-26495-y.
- Derived from this study: PubMed 34887772Gao J, Liu JY, Lu PJ, Xiao JY, Gao MD, Li CP, Cui Z, Liu Y. Effects of Evolocumab Added to Moderate-Intensity Statin Therapy in Chinese Patients With Acute Coronary Syndrome: The EMSIACS Trial Study Protocol. Front Physiol. 2021 Nov 23;12:750872. doi: 10.3389/fphys.2021.750872. eCollection 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Evolocumab in people with Acute Coronary Syndrome and Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor, run by Tianjin Chest Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Gao, PHD (+86-13820156072, gaojing2088@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in LDL-C (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04100434, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2020.